J&J, US Gov’t Commit $1 Bn More To Develop J&J’s COVID-19 VaccineBy
Johnson & Johnson (J&J) has expanded its partnership with the US government through a joint commitment from both parties to provide an additional $1 billion ($604 million from J&J and $454 million from the US government) to fund ongoing development of the company’s investigational COVID-19 vaccine.
Under an amendment to a previous agreement, J&J’s Janssen will commit approximately $604 million and the Biomedical Advanced Research and Development Authority, which is part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, will commit approximately $454 million to support an ongoing Phase III trial evaluating Janssen’s investigational COVID-19 vaccine candidate, JNJ-78436735, as a single-dose, in up to 60,000 volunteers globally. The partnership was initially announced in late March (March 2020).
In addition to the single-dose regimen study, Janssen has initiated a Phase III trial evaluating a two-dose regimen of the vaccine in up to 30,000 participants globally. Janssen says it will aim to enroll participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK and the US. The trial is being conducted in collaboration with the UK National Institute for Health Research, which funds healthcare research.
The two trials, the single-dose and two-dose regimens, will run in parallel. The company reported positive interim results from J&J’s ongoing Phase I/IIa clinical study, which is studying the safety profile and immunogenicity of both a single-dose and two-dose vaccination. The company reported that an interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated.
Source: Johnson & Johnson (funding) and Johnson & Johnson (Phase III trial)